Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
138505–138528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1987
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074 · JGS
American Monitor Corp.
Chemistry · 75d
Cleared Oct 20, 1987
PHARMACIA IGE EIA
K873077 · JHR
Pharmacia, Inc.
Immunology · 76d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K873112 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · CIJ
Roche Diagnostic Systems, Inc.
Chemistry · 64d
Cleared Oct 20, 1987
BILE ACIDS CONTROLS
K873342 · JJX
Sigma Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 20, 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K873344 · BZT
Medical Components, Inc.
Anesthesiology · 62d
Cleared Oct 20, 1987
SECURLINE FRANSEENE NEEDLE
K873369 · KNW
Precision Dynamics Corp.
Gastroenterology & Urology · 60d
Cleared Oct 20, 1987
TITAN GEL LDH REP SYSTEM
K873386 · CFE
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
HOYER SOLVET
K873395 · CAF
Infrasonics Corp.
Anesthesiology · 57d
Cleared Oct 20, 1987
TITAN GEL CPK REP SYSTEM
K873399 · JHX
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · JLS
Serono Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 20, 1987
BLOCK, BITE, INTUBATION
K873491 · JAY
B&B Medical Technologies, Inc.
Anesthesiology · 50d
Cleared Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · CIJ
Instrumentation Laboratory CO
Chemistry · 48d
Cleared Oct 20, 1987
BAKER TDM THEOPHYLLINE ASSAY
K873596 · KLS
Baker Instructions Corp.
Toxicology · 46d
Cleared Oct 20, 1987
A-QC CLINICAL CHEMISTRY CONTROL
K873611 · JJY
Arden Medical Systems, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
ACA URINE BARBITURATES SCREEN METHOD
K873623 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 42d
Cleared Oct 20, 1987
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
K873625 · JLM
Boots-Celltech Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
OSMOMETER MODEL 110
K873642 · JJM
Advanced Instruments, Inc.
Chemistry · 41d
Cleared Oct 20, 1987
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · GIO
Ventrex Laboratories, Inc.
Hematology · 41d
Cleared Oct 20, 1987
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
K873677 · BTI
Mountain Medical Equipment, Inc.
Anesthesiology · 36d
Cleared Oct 20, 1987
MULTICHEM CREATININE REAGENT S0917
K873725 · CGX
Simmler, Inc.
Chemistry · 35d
Cleared Oct 20, 1987
BERMUDA GRASS ALLERGEN DISC
K873770 · DHB
Incstar Corp.
Immunology · 34d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XP BEHIND-THE-EAR
K873798 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XL BEHIND-THE-EAR
K873799 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d